Label: TOPCARE STOOL SOFTENER- docusate sodium capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 12 to 72 hours
  • Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor                                

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel movements that lasts over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a stool softener laxative for more than 1 week

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

    adults and children 12 years and over

    take 1 to 3 softgels daily

    children 2 to under 12 years of age

    take 1 softgel daily

    children under 2 years

    ask a doctor

  • Other information

    • each softgel contains: sodium 7 mg
    • store at room temperature 15° to 30°C (59° to 86°F)
  • Inactive Ingredients

    FD&C RED NO. 40, FD&C YELLOW NO. 6, GELATIN BOVINE, GLYCEROL, POLYETHYLENE GLYCOL, PURIFIED WATER, SORBITOL.

  • Display Panel

    Image of carton

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007

    ©TOPCO RSEA0621

    QUESTIONS? 1-888-423-0139

    topcare@topco.com

    www.topcarebrand.com

  • INGREDIENTS AND APPEARANCE
    TOPCARE STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-761
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (OVAL) Size12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-761-251 in 1 CARTON07/20/2021
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/20/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - Reese Pharmaceutical (004172052)
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